Trials / Withdrawn
WithdrawnNCT02277561
Voxel Based Diffusion Tensor Imaging in Predicting Response in Patients With Brain Metastases Undergoing Whole Brain Radiation Therapy or Stereotactic Radiosurgery
Prediction of Response of Brain Metastases to Brain Irradiation Using Voxel Based Diffusion Tensor Imaging
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Albert Einstein College of Medicine · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting response in patients with brain metastases undergoing whole-brain radiation therapy or stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than is possible with a standard magnetic resonance imaging. The earlier ability to measure response may allow for consideration of alternative therapies at an earlier stage.
Detailed description
PRIMARY OBJECTIVES: I. To determine if voxel based diffusion tensor imaging will provide an early predictive assessment of therapy response, as compared to radiographic volumetric response criteria. OUTLINE: Patients undergoing whole-brain radiation therapy (WBRT) for a total of 10 fractions also undergo VB-DTI magnetic resonance imaging (MRI) at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing stereotactic radiosurgery (SRS) without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS. After completion of study, patients are followed up every 2 months for 6 months and then every 6 months until death.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | diffusion tensor imaging | Undergo VB-DTI |
| RADIATION | whole-brain radiation therapy | Undergo WBRT |
| RADIATION | stereotactic radiosurgery | Undergo SRS |
| PROCEDURE | contrast-enhanced magnetic resonance imaging | Undergo contrast-enhanced MRI |
| PROCEDURE | diffusion-weighted magnetic resonance imaging | Undergo DW MRI |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2014-10-29
- Last updated
- 2020-03-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02277561. Inclusion in this directory is not an endorsement.